Database for online accreditation process in Directorate for Accreditation of Kosovo (DAK-MIS) Abstract

Transcription

1 Database for online accreditation process in Directorate for Accreditation of Kosovo (DAK-MIS) Dr.Ibush Luzha Ministry of Trade and Industry, Str.Muharrem Fejza, n.n. Hospital Square Pristine, Kosovo, Abstract Directorate for Accreditation of Kosovo (DAK) is only National Accreditation Body in Republic of Kosovo, recognized by Government, which in accordance with international standards, assesses technical competences of the Conformity Assessment Bodies (CAB)s that deal with activities such as: testing, calibration, certification and inspection both in public and private sector. Till now application for accreditation and all other procedures for accreditation of CABs are carried out so that all the documents of the application and the receipt of the certificate of accreditation are conducted in the offices of DAK. By Management Information System (MIS), database of DAK (DAK-MIS), customers will have 100% documents online, starting from the application, check of documents, selection of non-conformities, through this database. DAK-MIS database will facilitate the work of DAK and CABs. The main goal of this paper is to inform the CAB's and other Interested Parties about DAK- MIS database. Key words: Database, accreditation, DAK, MIS, CABs. DAK Management Information System (MIS) 1. Online application for the accreditation process. 1.1 CAB (Conformity Assessment Body) can apply on-line on DAK official Web-Page at the DAK-MIS button, to be registered and get information for the accreditation procedure and respective documents needed to receive the accreditation. They need to be registered first at the pre-registration form fulfilling the following: Name of CAB (Name of the Company interested to receive accreditation) Address of the Company (official address, phone and address) Contact Person (Phone, address etc.) Number of employees

2 1.1.5 Type of accreditation scope: a. Testing / calibration laboratories b. Medical laboratories c. Inspection Bodies d. Product Certification Bodies e. Management systems Certification Bodies f. Certification Bodies for personnel Application request tariff (to be paid at the Bank before applying on-line at the DAK web page and uploaded the scanned document of the payment recipe on the official DAK web page during the time of CAB fulfilling the request application form) After this process finish, the system will generate to the CAB the username and password for further continuity at the DAK-MIS. 1.2 After CAB will finalized the pre-registration form and get the credentials to enter at DAK-MIS, CAB will enter at DAK-MIS system and download the proper documents needed to follow the accreditation process and is called the applicant for accreditation. In the meantime CAB if needed can request for an initial explanation meeting with the respective DAK officer, whereby he explains the whole accreditation procedure, fees and documents that CAB shall upload at DAK-MIS for accreditation procedure. The whole general information will be at official web site of DAK as well. During this meeting, the CAB representative get information that can receive the whole documentation package only electronically in DAK s webpage, not any more in hard copy at DAK offices. They will get this information at the DAK web site and in more details at DAK-MIS through credentials generated for them after fulfilling the pre-registration form. This package contains: - The accreditation procedure, according to the CAB request to be accredited - Application form according to CAB - Administrative order For accreditation fees - Procedures and obligations of the CAB The respective officer of DAK will receive the proper information from the pre-registration form fulfilled from the CAB regarding the type of the accreditation scope, number of employees, CAB location and contact details and bank invoice for the payment proceed for the pre-registration process. 1.3 The CAB is considered to have applied for accreditation once it has filled out electronically the preregistration form, paid the pre-registration fee and the got the CAB credentials (username, password) accessing the DAK MIS system according to the respective standards and uploading the needed documentations in accordance with the standard requirements for which it is seeking accreditation. Once it upload the full set of documentation need for the accreditation process, the CAB shall declare whether it wants a pre-assessment visit through fulfilling a request form for that electronically on DAK- MIS. The respective accreditation officer performs: The analysis of the accreditation scope requested by the CAB The analysis of the technical experts listed for the assessment of the procedures, The respective accreditation officer from DAK makes a formal evaluation process within 7 working days: If there are the type of non-conformities when the documents submitted by the applicant do not fulfil the requirements of the standard for which the accreditation is requested, the accreditation process will be stopped the whole documentation part will be archived on DAK-MIS and the CAB will be informed officially.

3 If there are type of non-conformities where proper corrections need to be done from CAB, CAB here needs to close all the nonconformities and to upload again the documentation of undertaken corrective actions to the DAK-MIS system, and after the CAB will go ahead with the accreditation process. 1.4 Contractual Agreement between DAK and CAB The respective officer of DAK calculates and determines the preliminary cost, which includes: preassessment visits, assessment visits, issuance of certificates in accordance with predetermined fees as per Administrative Instruction, pertaining to the accreditation scope and the documents submitted by the CAB. Agreement of the preliminary cost from CAB: If the CAB agrees with calculated costs, DAK and CAB sign the agreement. This agreement will be uploaded and saved on DAK-MIS system. If the CAB doesn t agree the accreditation procedure is stopped and all the documentation is archived electronically on DAK-MIS. The deadline for approval of the preliminary cost by CAB is 15 working days. When the deadline is over and the CAB requests to be accredited, the procedure will start again from the beginning. If the CAB accepts the calculated preliminary cost, it must pay 50 % of it from this stage and 50% at the end of the process. The respective officer of DAK prepares the approximate pre-assessment cost. This cost takes into consideration: Pre-assessment visit and whether foreign assessors are being used or not. The judgment of technical assessors relating to the duration of assessment and number of witnessing visits. The first cost is included in the second approximate cost. DPA sends the second cost to CAB. If CAB doesn t agree with the second cost, the accreditation procedure is stopped and documentation is archived electronically on DAK-MIS. If the CAB agreed with the second cost, CAB will pay 50% of the contracted amount before the organization of the assessment visit. The assessment visit will not be performed if the CAB has not paid 80% of the second invoice. 1.5 Assessment Team The assessment team is appointed taking into account the accreditation standard against which the CAB is requesting accreditation, the technical scope submitted to accreditation. The Director of Accreditation Department within 7 working days from the date of submission of the formal evaluation by the respective officer of DAK, based on the analyses of recourses and decisions taken from such analysis, determines the composition of the assessment team (technical experts listed for the assessment of the procedures). Proper templates need to be generated and saved on DAK system where predefined assessors/lead assessors/experts are part of this procedure. This assessment team is attached to and linked to the CAB applied for the accreditation process. If the list of technical experts does not include experts that cover the scope for which the CAB seeks accreditation, then the respective officer of DAK informs the Director of the Directorate for Accreditation and Development to make other decisions, i.e. finding assessors/lead assessors/ experts. The use of external assessors by DAK will be done only in cases when there are no internal human resources available or when the applicant requests it. All technical experts need to be declared and entered on the DAK-MIS system, to be ready to create the evaluation team for the next requests for the accreditation process from different CAB s.

4 The accreditation team need to be registered on the DAK-MIS system and updated regularly by the respective officer of DAK, and for each of them it will be generated the system credentials: username and password. The members of the assessment team are chosen by the Director of Accreditation from the List of DAK s assessment personnel, based on their competence and related to the accreditation scope for which accreditation was requested. This list will be shown on the CAB account of DAK-MIS system, where DAK informs the CAB on the composition of the assessment team and awaits the approval, in accordance with the form of notification of the names of the team participants and its approval, DAK-FO-004. The approval of the assessment team may be done electronically on the system where CAB representative and assessment team staff will assign the approval online on the DAK-MIS system through the proper form. If the CAB agrees for the assessment team, then the procedure continues; otherwise different assessor names are proposed and the new ones proposed need to be entered on the system and finalizing and updating the new assessment team per the selected CAB. Complete or partial disapproval of the assessment team by the CAB shall be justified through a proper template form on the system. The final decision on the assessment team is made by the General Director of the DAK. The assessment team initially declares to have no conflict of interest with the CAB under assessment and they shall sign online the confidentiality agreement, impartiality and conflict of interest. The assessment team get access over the DAK-MIS system on the documentation of the specific CAB within 7 working days from the date of its approval through internet/intranet using assessment team credentials accessing DAK-MIS system. The assessment team meets in the DAK premises, where it reviews the accreditation scope, (the list of analysis of the accreditation program), recommends a date for the assessment visit and the assessment plan. After this meeting, the respective officer of DAK notified the CAB about the assessment date and attaches the notification forms such as: Notification Form of the assessment date and its approval; Assessment Plan; All this process is done electronically on the DAK-MIS system and the CAB is obliged to send to DAK, within seven working days, the approval or not of the assessment plan, assessment team and the assessment date, through the electronic approval process on the DAK-MIS system. 1.6 Assessment Evaluation Procedure Assessment procedure Document Control The control of the documentation of the Management System is done by the lead assessor, who makes an assessment in accordance with the respective standard, and the technical assessor makes the technical assessment. The respective forms are filled out electronically on the DAK System: Check list according to the respective standard The lead assessor s report according to the standard requirements Corrective actions form Pre-assessment The pre-assessment visit is done in accordance with the requirements of assessment visit and is carried out in the premises of the CAB.

5 If there are serious nonconformities found during this visit, it is the obligation of the CAB to take corrective action in their regard and the nonconformities found in the documentation. The nonconformities are reported in writing in a pre-assessment report, which will be uploaded and stored on the DAK System at the pre-assessment module. The maximum deadline to solve the nonconformities is three months. After carrying out the corrective actions, the CAB notifies DAK in writing about having performed these corrective actions and for its availability to await the assessment visit and upload the same document on the DAK-MIS system at his account space Assessment visit The assessment process is carried out according to the procedure and requirements of standard items. The purpose of the assessment visit is to verify whether the CAB meets the requirements of the respective standard and verify the technical competencies already assessed during the pre-assessment and the document control On-site visit Within two weeks from the assessment, the assessment team provides to the respective officer of DAK all the documents received from DAK, the assessment report according to the CAB and all the filled out forms, and the latter, after having reviewed the whole practice, sends the assessment report to the CAB, which has the right to send within ten days the remarks and suggestions about the report. The respective officer of DAK cooperates with the lead assessor on whether to involve the remarks of the CAB in the report. The whole documentation presented in hard copy till now will be uploaded electronically on DAK System. The deadline for carrying out the corrective actions for a new CAB is three months. The CAB, within the specified deadlines, shall send to DAK a report about the solutions of the nonconformities (comments, scanned document solving the non-conformities, the scanned certificates), the document will be uploaded on DAK-MIS system as well. The lead assessor, in cooperation with the assessment team assesses how the CAB solves the nonconformities; if necessary the assessment team may send additional information to the CAB (electronically at the CAB account space on the DAK System). For failure to solve the nonconformities, the CAB may ask to postpone the deadline for carrying out the corrective or preventive actions only once. The request to postpone the deadline is done through the DAK System fulfilling the proper form electronically. The respective officer of DAK approves or not the postpone process which cannot be more than one month and the proper document will be uploaded on DAK-MIS System. In case the CAB does not solve the nonconformities within the deadline, then the lead assessor requests the initiation of the rejection procedure of the accreditation of the unsolved nonconformities. If the CAB has solved the nonconformities, the lead assessor reports electronically on DAK System fulfilling the form. The respective officer of DAK, after reviewing the practice of the conclusion of nonconformities, provides the whole above-mentioned documentation to the Accreditation Council, for analysis of the assessment reports, the conclusion of the nonconformities found during the assessment procedure. The respective officer of DAK conducts the proper preparations for the meeting of the Accreditation Council (AC). After reviewing the documentation, the Chairman of the AC proposes to the DAK Director to render a decision, by making a report, fulfilled electronically should be saved on the DAK-MIS System. In the DAK-MIS system should be entered all (around 30) members of the Accreditation Council and should be generated all credentials to access the DAK-MIS system to check and control the proper documentation part (from CAB and from assessment team) of the proper CAB which under the accreditation process.

6 1.7 Decision The respective officer of DAK, after having reviewed the materials electronically on the DAK-MIS System submitted by the assessment team, the assessment report and the proposals of the Accreditation Council, renders the final decision for the accreditation of the CAB, this document as well will be saved on DAK System as well. Director of DAK shall render a decision within 15 working days from the date the documentation was presented to him. Director of DAK fills out the respective form and sends it to the respective officer of DAK for the notification of the CAB, about the accreditation decision the whole notification process is done electronically as well through the DAK-MIS System to the CAB. If the decision is positive, then the procedure for compiling the certificate is carried out, according to the respective procedure (this process will be done in DAK-MIS System as well). The CAB receives within 7 working days electronically by DAK-MIS system and in hard copy as well: The Accreditation Certificate, including the annex of the accreditation scope Rights and obligations of CAB procedure Copy of assessment report Procedure for using the accreditation symbol In the end, the CAB is issued the final financial invoice on what it shall pay (the certificate and other additional actions that may have been carried out during the accreditation procedure). The accreditation is valid for a period of four years. The whole payment recipe and other documents will be downloaded on DAK-MIS system as well. If the decision is negative, the CAB is informed of the rejection of accreditation (electronically and officially) and it is informed of its right to appeal to the Professional Council. The CAB may appeal within 14 days from the date of notification of the rejection. After the CAB files the appeal in the offices of DAK, the appeal procedure with the Professional Council (PC) is followed. The whole documentation, irrespective of the decision, is forwarded to the respective officer, who reviews the file and the documents and then sends it to the Quality Manager for protection according to the respective procedure of record control. The whole process is going through the archiving process as well in DAK System based on the procedure of record control as well. The Accreditation Directorate places the accredited CAB-s in the list of accredited entities in DAK s webpage. From the DAK-MIS System the announced to the DAK web page goes automatically. References: 1. ISO/IEC 27001, specifies requirements for an information security management system (ISMS) "Learning Zone MIS: Time to plunge into automated systems." Printing World. 6 April Shim, Jae K. and Joel F. Siegel. The Vest Pocket Guide to Information Technology. John Wiley & Sons, 2005.